Olive Oil v Prostate Cancer Foundation Diet for Treatment of Prostate Cancer

Not Applicable

Completed

• Conditions: Prostate Cancer
• Interventions: Other: Plant- based, olive oil diet; Other: Prostate Cancer Foundation diet

• Registration Number: NCT03084913
• Lead Sponsor: The Miriam Hospital

Brief Summary

This study compared a plant-based, olive oil diet to the diet recommended by the Prostate Cancer Foundation for weight loss and improvement in some laboratory biomarkers.

Detailed Description

Dietary treatment of overweight/ obese men with prostate cancer has not been well studied. As men with prostate cancer who are overweight/ obese are at an increase risk of recurrence, metastasis and mortality, elucidating a diet that will both improve biomarkers for prostate cancer and lead to long-term weight management could improve survivorship. The primary objective of this proposal is to compare a plant-based, olive oil (PBOO) diet to a conventional diet for weight loss and improvement in metabolic biomarkers (specifically fasting insulin, glucose, and triglycerides) for overweight/ obese men diagnosed with prostate cancer on surveillance or who have had an asymptomatic biochemical failure after primary therapy. The secondary objective is to determine which diet will be more acceptable for long term use. Participants will consume for 8 weeks each a conventional diet for treating prostate cancer and a PBOO diet for weight loss and improvement in biomarkers with random assignment to the diet order. They will choose one of the diets for 6 months of follow-up. Blood samples and body weight will be obtained pre- and post diet and after 6 months of follow-up and compared between the diets. Based on earlier work by colleagues of the PI, it is anticipated that the PBOO diet will result in better weight loss and biomarkers and will be more acceptable for long-term weight management. This protocol has the potential to elucidate a diet that will improve the body weight and survival of men with prostate cancer.

Study Timeline

• Study Start: 2015-01-01
• Primary Completion: 2016-11-30
• Study Completion: 2016-11-30
• Status Verified: 2017-03
• Study First Submitted: 2017-03-09
• Study First Submitted QC: 2017-03-20
• Last Update Submitted: 2017-03-20
• Study First Posted: 2017-03-21
• Last Update Posted: 2017-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 30

Inclusion Criteria

• prostate cancer, BMI 25.0 to 40.0 kg/m2

Exclusion Criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
plant- based, olive oil diet	Plant- based, olive oil diet	Intervention: 8 weeks of a plant-based, olive oil diet
Prostate Cancer Foundation diet	Plant- based, olive oil diet	Intervention: 8-weeks of a Prostate Cancer Foundation diet
Prostate Cancer Foundation diet	Prostate Cancer Foundation diet	Intervention: 8-weeks of a Prostate Cancer Foundation diet
plant- based, olive oil diet	Prostate Cancer Foundation diet	Intervention: 8 weeks of a plant-based, olive oil diet

Primary Outcome Measures

Name	Time	Method
weight loss	8 weeks

Secondary Outcome Measures

Name	Time	Method
improvement in in fasting blood glucose and insulin	8 weeks